Cleared Traditional

K230455 - Enamel Coating Resin

K230455 is an FDA 510(k) clearance for Enamel Coating Resin, manufactured by Rizhao Huge Biomaterials Company, Ltd.. The device is a Class 2 Dental device with product code EBC cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K230455 · Rizhao Huge Biomaterials Company, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2023
Decision
154d
Days
Class 2
Risk

K230455 is an FDA 510(k) clearance for the Enamel Coating Resin. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Rizhao Huge Biomaterials Company, Ltd. (Rizhao City, CN). The FDA issued a Cleared decision on July 25, 2023 after a review of 154 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3765 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Rizhao Huge Biomaterials Company, Ltd. devices

FDA 510(k) Submission Details - K230455

510(k) Number K230455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2023
Decision Date July 25, 2023
Days to Decision 154 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 127d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBC Device Classification - Class 2, Special Controls

Product Code EBC Sealant, Pit And Fissure, And Conditioner
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3765
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EBC Sealant, Pit And Fissure, And Conditioner

All 85
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K230455.
Any-Com Seal
K260819 · Mediclus Co., Ltd. · May 2026
Parkell Pit and Fissure Sealant
K243254 · Parkell, Inc. · Aug 2025
UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio
K232498 · Ultradent Product, Inc. · Aug 2023
BA Pit & Fissure Sealant
K190998 · Apex Dental Materials, Inc. · Nov 2019
Helioseal F Plus
K190339 · Ivoclar Vivadent, AG · Jul 2019
Pulpdent (Activa) Pit and Fissure Sealant with MCP
K172169 · Pulpdent Corporation · Jan 2018